Abstract

Tumor Mutational Burden as a Biomarker for Immunotherapy – Clinical Feasibility in NSCLC, Melanoma and Advanced Urothelial Carcinoma

David Fabrizio, Leader, Foundation Medicine

Biomarkers capable of predicting response to checkpoint inhibitor therapies represent a significant clinical need. Increased tumor neo-antigenic burden has been linked to PD1/PD-L1 therapeutic response in several conditions including metastatic melanoma, non-small cell lung carcinoma and microsatellite instable (MSI-H) colorectal cancer (CRC). However, the challenges and high cost associated with neo-antigen discovery has shifted focus towards more efficient methods of response stratification. As such, tumor mutational burden (TMB) determination from comprehensive genomic profiling (CGP) has emerged as a potential solution. Herein, we demonstrate the clinical utility of TMB for predicting response to checkpoint inhibitor blockade across three indications including NSCLC, metastatic melanoma and advanced urothelial carcinoma using the Foundation One platform.